Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation
NCT ID: NCT05863286
Last Updated: 2023-05-22
Study Results
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Basic Information
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UNKNOWN
NA
28 participants
INTERVENTIONAL
2022-12-30
2024-03-31
Brief Summary
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Detailed Description
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1. Patient questionnaire: a questionnaire will be recorded by the examiner including the Chief complaint, Personal data, and Medical history.
2. Consent: Informed consent will be obtained from patients to participate in the study.
3. Clinical examination: TMJ examination with specific emphasis on the TMJ regarding pain, clicking, maximum inter-incisal mouth opening, lateral excursions, and muscle examination is done (Inspection and palpation).
o operative procedures:
• The surgical field will be scrubbed and prepared in a standard sterile fashion using alcohol and topical anesthesia is applied at point of needle insertion
A-Botulinum Toxin Type A injection:
BTX-A vial will be reconstituted with normal saline to obtain a 10 U/0.1 ml solution, 0.25 ml of this solution containing 25 U BTX-A will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length.
B-The placebo comparator Injection:
Patients in the placebo arm will receive equivalent volumes of placebo solution (Normal Saline).
• Procedure
\- With the patient sitting in an upright position on the dental chair, the lateral ptreygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection.
According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with BTX-A or normal saline
\- The patient will be instructed to remain in an upright position for 6 h (to reduce diffusion into pharyngeal muscles which may cause dysphagia and nasal regurgitation).
\- Patients will be recalled weekly during the first month, then monthly after 3 months
* Post-operative care:
Paracetamol 1000 mg will be prescribed as needed Any excessive mouth opening should be avoided Soft diets are advised in the first 48 hours after injection
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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botulinum toxin type A injection in lateral pterygoid muscle
Botulinum toxin type A vial will be reconstituted with normal saline to obtain a 10 U/0.1 ml solution, 0.25 ml of this solution containing 25 U BTX-A will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length.
The Lateral pterygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection. According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with BTX-A
Botulinum toxin type A
Botulinum toxin is produced by the gram-positive, anaerobic, spore-forming bacterium Clostridium botulinum, and is one of the most lethal biological toxins known to man.
Botulinum toxin has seven antigenically different serotypes and exerts a paralytic action by rapidly and strongly binding to presynaptic cholinergic nerve terminals. It is then internalized and ultimately inhibits the exocytosis of acetylcholine by decreasing the frequency of acetylcholine release. Without its nerve supply, the muscle fiber will deteriorate; however, the muscle will regain its strength as the nerves regenerate.
Placebo "Saline 0.9%" injection in lateral pterygoid muscle
0.25 ml of normal saline will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length.
The Lateral pterygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection. According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with normal saline
Botulinum toxin type A
Botulinum toxin is produced by the gram-positive, anaerobic, spore-forming bacterium Clostridium botulinum, and is one of the most lethal biological toxins known to man.
Botulinum toxin has seven antigenically different serotypes and exerts a paralytic action by rapidly and strongly binding to presynaptic cholinergic nerve terminals. It is then internalized and ultimately inhibits the exocytosis of acetylcholine by decreasing the frequency of acetylcholine release. Without its nerve supply, the muscle fiber will deteriorate; however, the muscle will regain its strength as the nerves regenerate.
Interventions
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Botulinum toxin type A
Botulinum toxin is produced by the gram-positive, anaerobic, spore-forming bacterium Clostridium botulinum, and is one of the most lethal biological toxins known to man.
Botulinum toxin has seven antigenically different serotypes and exerts a paralytic action by rapidly and strongly binding to presynaptic cholinergic nerve terminals. It is then internalized and ultimately inhibits the exocytosis of acetylcholine by decreasing the frequency of acetylcholine release. Without its nerve supply, the muscle fiber will deteriorate; however, the muscle will regain its strength as the nerves regenerate.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. The willingness of the patient to receive relative painful injections and to follow instructions
Exclusion Criteria
2. Drug-induced TMJ Hypermobility
18 Years
60 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Amr Ehab Shaaban
Amr Shaaban, BDS "Prinicipal Investigator"
Principal Investigators
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Hamida Refai, Doctor of dental science
Role: STUDY_DIRECTOR
Cairo University
Locations
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Faculty of Dentistry, Cairo university
Cairo, Elmanial, Cairo, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec;69(12):2962-70. doi: 10.1016/j.joms.2011.02.128. Epub 2011 Jul 16.
Other Identifiers
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11 12 22
Identifier Type: -
Identifier Source: org_study_id
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